Policies and Procedures
Policies and Procedures
I. Membership
A. Appointment of Members
The Portland Area Indian Health Service (IHS) Director, or designee, shall appoint members to the Portland Area IHS Institutional Review Board (IRB) taking into consideration the recommendations of the Portland Area IHS IRB Chair, tribes. IRB members, and the Northwest Portland Area Indian Health Board (NPAIHB). (Note: The term “Director” herein refers to the Portland Area IHS Director or designee; the term “Chair” herein refers to the Portland Area IHS IRB Chair or designee.) The Chair shall be designated from the appointed members of the IRB by the Director. Appointments to the IRB shall conform to composition requirements (see Section D). Members who are Federal employees may serve on the committee as part of their duties. Community members and non-Federal employees will not receive payment for their services on this committee.
B. Term of Appointment
The maximum term of appointment, including that of the Chair, shall be five (5) years. Appointments may be renewed at the Director’s discretion upon recommendation of the Chair. Office for Human Research Protections (OHRP) trainings for members shall be provided as necessary, but not to exceed on OHRP training every two years per member, and as funds are available.
C. Removal
Any IRB member may be removed by the Director for causes related to conduct, attendance, performance of assigned duties, or administrative activities. Members may not be removed solely on the basis of their opinions or decisions related to matters coming before the IRB. Appeal is limited to request for reconsideration addressed to the Director.
D. Composition
1. Qualifications in General
Members should possess a sincere interest in the activities of the IRB. The IRB as a whole should be comprised of members with diverse backgrounds and should have the scientific, administrative, and cultural understanding necessary to review the research activities assigned to it and appropriate to the unique circumstances of the Portland Area. There shall be at least eight (8) and no more than twelve (12) committee members. The Chair will appoint an IRB Coordinator.
2. Gender
There shall be more than one male and one female voting member.
3. Diversity
Members should represent a variety of professional disciplines related to the types of research coming before the IRB. At least one voting member shall possess primary expertise in a non-scientific area. At least 50% of the membership will be of American Indian and Alaskan Native ancestry.
4. Community Representation
If possible, the IRB shall include at least one member who is not employed with IHS, and who is not part of the immediate family of a person employed with the Portland Area IHS.
5. Vulnerable Subjects
When research is reviewed dealing with a category of vulnerable subjects (e.g., prisoners, children, pregnant women, and mentally disable people), the IRB shall include in its reviewing body one or more individuals who have, as a primary concern, the welfare of these subjects.
6. Physician Membership
There shall be at least one physician IRB member.
E. Vacancies
Vacancies caused by resignation or departure of IRB members may be filled by appointment of the Director upon recommendation of the Chair.
The appointment will be for five (5) years. If the vacancy is not filled, the remaining members shall constitute the pool on which a quorum is based.
II. MEETINGS
A. Frequency
Meetings will be held on-call of the Chair as needed. Three members of the IRB may request a meeting to be called, which will be promptly scheduled by the Chair.
B. Quorum
To take action on research and publication review, a quorum shall include the presence of at least five (5) members, including the Chair, one physician, and one Portland Area voting member, whose primary concerns are in non-scientific areas. This quorum shall be present at the beginning and throughout the period of deliberation and decision-making.
C. Decisions
When a quorum is present and an issue presented, a majority of voting members is sufficient to decide. In cases where a consensus (unanimous) decision is not achieved, the minutes shall reflect the distribution of favorable and unfavorable votes (see Section F).
D. Guests
Non-members of the IRB may be present at meetings with the permission of the IRB Chair. Guests are not permitted to engage in discussion with the IRB or its members at meetings unless invited to do so by the Chair.
E. Agenda
The general agenda for scheduled IRB meetings is as follows:
1. Review of prior meeting minutes.
2. Presentation of expedited reviews.
3. Presentation of expedited approval modifications of existing studies.
4. Continuing review of existing studies (as applicable).
5. Review of newly proposed or resubmitted research (initial review).
6. Review of reports and abstracts for publication approval.
F. Minutes
1. The minutes of each meeting should contact at minimum:
a. Quorum of voting members by name
b. Guests present by name
c. All actions taken by IRB
d. Vote on actions that do not achieve consensus: those for, against, and abstaining
e. Written summary of discussion
f. Explanation of the basis for requiring changes or disapproving research
g. Dissenting members’ reports and opinions
h. Record of IRB members’ conflict of interest with statement that this member did not participate in the review except to provide requested information
i. Scheduled date and location for next meeting, if known
j. Starting and ending time of meeting
2. Minutes or portions thereof may be provided to non-members of the IRB at the discretion of the Chair.
III. IRB Authority and Responsibility
Under authority granted by the Director, by IHS policy, and in conformity with 45 CFR 46, the Portland Area IHS IRB is responsible to:
A. Review and Approve Research
The Portland Area IHS IRB shall have the responsibility to review, and the authority to approve or disapprove, all research activities that use IHS facilities, data, staff resources, or funding in the Portland Area; moreover, they shall retain said responsibility to previously approved activities. The Portland Area IHS IRB shall be responsible for requiring necessary documentation on which to base their decisions. If requested by tribes, the Portland Area IHS IRB will review research occurring in Indian communities that does not use IHS facilities, data, staff, or funding as a courtesy and will provide recommendations to the tribes regarding such research. Research proposals involving IHS facilities, data, staff, or funding must also be reviewed by the Headquarters-Rockville, MD Combined IHS IRB (hereinafter referred to as the National IRB), unless the Portland Area IHS IRB determines them to be exempt. All proposals for approval shall be complete.
B. Suspend or Terminate Approval of Research
The IRB shall have the authority to suspend or terminate approval of research, as qualified above, that is not being conducted in accordance with IRB decisions, conditions, and requirements, or that has been associated with unexpected harm to subjects.
C. Imposed Condition and Requirements on the Duration of Disapproval
Disapproval of an activity, termination or suspension of a previously approved activity, or imposition of conditions or requirements for approval shall not be voided or modified by any other authority if the IRB actions were the result of a process fully in conformance with written IRB procedures.
D. Conduct Joint Reviews with the National IRB
All IRB actions in Part A and B of IRB Authority and Responsibility are subject to administrative review by the National IRB. The National IRB
shall have the authority to disapprove, impose additional conditions or requirements, or take other action in addition to those of the Portland Area IHS IRB. The National IRB shall not have the authority to overturn disapprovals or modify or reduce actions described in Part C of this action.
IV. RECORDS
A. The IRB shall maintain the following records for a minimum of three (3) years after termination of the last IRB approval period for the activity:
1. Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposal, approved sample consent documents, progress reports submitted by research investigators, and reports of injuries to subjects.
2. Minutes of IRB meetings.
3. Minutes of continuing review activities.
4. Copies of all correspondence between the IRB and the research investigators.
